BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BONE SCREW 6.5X40 SELF-TAP

    MDR report key: 7050162 · Received November 21, 2017

    Report

    Report Number
    0002648920-2017-00710
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    December 17, 2013
    Report Date
    December 10, 2018
    Manufacturer
    ZIMMER MANUFACTURING B.V.
    Product Code
    MRA
    PMA / PMN Number
    PK934765
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. IT WAS IDENTIFIED AN INTERNAL SOFTWARE ERROR PRODUCED AND SUBMITTED AN INVALID DEVICE PRODUCT CODE IN THE PREVIOUS SUBMISSIONS RELATED TO THIS REPORTING. THE DEVICE PRODUCT CODE HAS BEEN UPDATED WITH NO FURTHER CHANGES. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: MODULAR NECK J 12/14 NECK TAPER USE WITH +0 HEADS ONLY, LOT#61498558, ITEM#00784803400; SHELL WITH CLUSTER HOLES POROUS 60 MM O.D. SIZE MM FOR USE WITH MM LINERS, ITEM#00875706001, LOT#61615671; MODULAR FEMORAL STEM PRESS-FIT PLASMA SPRAYED CEMENTLESS SIZE 10, ITEM#00771301000, LOT#61548895; BONE SCR 6.5X20 SELFTAP LOT#61515065, ITEM#00625006535; BONE SCR 6.5X40 SELFTAP, LOT#6171799, ITEM#00625006520; METASUL TAPER LINER MM/40, ITEM#00877001440, LOT#2544861; METASUL HEAD 40, 12/14, SIZE M /0, LOT#245769, ITEM#00877004002. THE REPORTED EVENT IS CONFIRMED THROUGH RECEIPT OF OPERATIVE NOTES. NO DEVICES WERE RETURNED; THEREFORE, THE VISUAL AND DIMENSIONAL INSPECTIONS WERE NOT PERFORMED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED. THE COMPATIBILITY CHECK WAS REVIEWED AND NO ISSUES WERE NOTED. THE REPORTED DEVICES WERE IN-VIVO FOR 2 YEARS 5 MONTHS POST-IMPLANTATION. THE REVIEW OF THE INITIAL OP NOTES IDENTIFIED THAT THE PATIENT HAD GOOD EXTENSION AND NO IMPINGEMENT. IT ALSO SUGGESTED THAT THE HIP DID NOT DISLOCATE AT 60 DEGREES OF EXTERNAL ROTATION. THE REVIEW OF THE REVISION SURGERY NOTES SUGGESTED THAT THE PATIENT EXPERIENCED PAIN. THE NOTES ALSO CONFIRMED CLOUDY FLUID IN THE HIP JOINT AS WELL AS LOOSENING OF THE STEM WITH A SIGNIFICANT AMOUNT OF FIBROTIC MATERIAL. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565- 2017-01265, 0001822565-2017-01269, 0001822565-2017-01270, 0002648920-2017-00708, 0002648920-2017-00709.

    Description of Event or Problem · 1

    NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 1

    LEGAL COUNSEL FOR PATIENT REPORTED THAT PATIENT UNDERWENT A RIGHT HIP REVISION APPROXIMATELY TWO YEARS POST-IMPLANTATION DUE TO INFECTION. THIS REPORT IS BASED ON ALLEGATIONS SET FORTH IN PLAINTIFF¿S COMPLAINT, AND THE ALLEGATIONS CONTAINED THEREIN ARE UNVERIFIED. MEDICAL RECORDS INDICATED THE PATIENT WAS REVISED DUE TO PAIN THAT BEGAN APPROXIMATELY THREE (3) MONTHS POST-OPERATIVELY AND EVIDENCE OF COMPONENT LOOSENING FROM RADIOGRAPHS. THE OPERATIVE REPORT NOTES CLOUDY FLUID, LOOSENING OF THE FEMORAL STEM, AND DEBRIDEMENT OF FIBROTIC MATERIAL AND NONVIABLE TISSUE, ALL INDICATIVE OF INFECTION. ALL COMPONENTS WERE REMOVED AND REPLACED WITH CEMENT SPACERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827977 BONE SCREW 6.5X40 SELF-TAP HIP, PROSTHESIS MRA ZIMMER MANUFACTURING B.V. N/A 61649205

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R